SF BAY AREA PSR & HEALTH CARE WITHOUT HARM

The San Francisco Bay Area Chapter of Physicians for Social Responsibility is partnering with the national coalition, Health Care Without Harm, and the environmental subcommittee of California, Chapter 1 of the American Academy of Pediatrics (AAP) in an effort to remove Di (2-ethylhexyl) phthalate (DEHP) from use in Neonatal Intensive Care Units (NICUs).

DEHP is used as a plasticizer of polyvinyl chloride (PVC) in the manufacture of a wide variety of consumer products. Plasticizers provide PVCs with characteristics such as flexibility, strength, bondability and allow PVC to be softened and shaped into many designs without cracking or leaking. DEHP is currently the only phthalate plasticizer used in PVC medical devices. By weight, PVC-based medical devices contain 20%–40% DEHP.

Because DEHP is not bound to the PVC material, it leaches into many IV and enteral formulas/solutions, including whole blood, plasma, total parenteral and enteral nutrition solution, and other solutions. DEHP leaching also may occur during sterilization and irradiation. The rate of DEHP leaching also depends on storage conditions (e.g. temperature, contact time, agitation). DEHP is lipophilic and, therefore, leaches preferentially into lipid containing solutions.

Studies conducted for the governments of the United States, Canada, and the European Union have all concluded that exposures to di(2-ethylhexyl) phthalate (DEHP) are of concern to some patient populations and subsets of the general population. Especially vulnerable are healthy infants and toddlers, pregnant and lactating women, and patients undergoing certain medical procedures. All of the government-led studies point to the need for action to reduce DEHP exposure in vulnerable populations.

In Summer 2002, the FDA issued a guidance on DEHP. In the guidance, the FDA's recommends that manufacturers consider the feasibility of replacing PVC containing DEHP with either alternative materials or plasticizers, or using coatings that may minimize patient exposure to DEHP.

Staff and SF PSR members are working with several Bay Area hospitals to inventory their NICU supplies to assist in identifying products that contain PVC. If you would like to work with us, please contact us at 510-845-8395.

News Release: Health groups call on FDA to require labeling of medical devices for vinyl chemical

Download a list of medical devices that do not contain DEHP.

CMA Resolution: PVC Plastic Use by Health Care Facilities